Gefitinib in Treating Patients With Metastatic Breast Cancer That Has Progressed After Antiestrogen and Nonsteroidal Aromatase Inhibitor Therapy

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed breast cancer
• Radiological and/or clinical evidence of metastatic disease
• Progressive disease after prior therapy with an antiestrogen (e.g., tamoxifen or faslodex) and a nonsteroidal aromatase inhibitor (e.g., anastrozole or letrozole) in the adjuvant and/or metastatic setting\* NOTE: \*Endocrine therapy must be the last treatment before study entry
• Unidimensionally measurable disease
• No rapidly progressive visceral metastases
• No uncontrolled CNS metastases
• Hormone receptor status:
• * Estrogen receptor and/or progesterone receptor positive
• PATIENT CHARACTERISTICS:
• Age
• 18 and over
• Sex
• Not specified
• Menopausal status
• Postmenopausal, defined as any of the following:
• * Natural menopause with at least 1 year since last menses
• * Radiation-induced oophorectomy with last menses more than 1 year ago
• * Chemotherapy-induced menopause with 1 year since last menses and serum follicle-stimulating hormone, luteinizing hormone, and plasma estradiol levels in the postmenopausal range
• * Surgical castration
• Performance status
• ECOG 0-2
• Life expectancy
• Not specified
• Hematopoietic
• Not specified
• Hepatic
• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• Transaminases no greater than 2.5 times ULN
• No severe or uncontrolled hepatic disease
• Renal
• No severe or uncontrolled renal disease
• Cardiovascular
• No severe or uncontrolled cardiac disease
• Pulmonary
• No severe or uncontrolled respiratory disease
• No evidence of clinically active interstitial lung disease
• * Asymptomatic chronic stable radiographic changes allowed
• Other
• No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix, contralateral breast cancer, or nonmelanoma skin cancer
• No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up
• No other severe or uncontrolled systemic disease
• No known hypersensitivity to any excipients of gefitinib
• No unresolved chronic toxicity greater than grade 2
• PRIOR CONCURRENT THERAPY:
• Biologic therapy
• No concurrent biologic agents
• Chemotherapy
• No more than 1 prior chemotherapy regimen for metastatic breast cancer
• No concurrent chemotherapy
• Endocrine therapy
• See Disease Characteristics
• No concurrent hormonal therapy
• Radiotherapy
• Prior radiotherapy allowed
• No concurrent radiotherapy to any metastatic site
• Surgery
• No surgery within 4 days after study drug administration
• Other
• No prior epidermal growth factor receptor inhibitor therapy
• More than 30 days since prior investigational drugs
• No concurrent use of any of the following:
• * Phenytoin
• * Carbamazepine
• * Rifampin
• * Phenobarbital
• * Hypericum perforatum (St. John's Wort)
• No concurrent systemic retinoids
• No other concurrent investigational drugs or treatments
• No other concurrent anticancer treatments
• Concurrent bisphosphonates for the treatment and prevention of bony metastases are allowed provided therapy was initiated before study enrollment\* NOTE: \*Bisphosphonates may be initiated during study participation for the treatment of hypercalcemia only